Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Silver Nitrate

Criteria

Inclusion Criteria:

• Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy.

• Recurrent and symptomatic malignant pleural effusion.

• Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray.

• Karnofsky Performance Status >30

• Agreement to participate of the study by signing of the Informed Consent Term.

Exclusion Criteria:

• Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count).

• Active pleural or systemic infection.

• Massive skin neoplastic infiltration.

• Inability of understanding the pain scale.

• Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).

• Refusal to participate of the study.